Not a Bolt-on System!

Compliance is Both Top Down and Bottom Up.

Foster a team based compliance culture and ensure everyone is involved, responsible and works together towards the
desired quality outcomes.

Real-Time QMS Visibility

Oversee any project or QMS related progress through the centralized QMS control. Simple and productive. Not adding another layer of bureaucracy, nor interfering/imposing upon the project routine, nor the employees’ daily routine.

Handle audit files with ease, organize your QMS and save your team 100's of hours of documentation and compliance work!

Quality Manual

Establish your quality manual in a day! Correlates directly to qmsWrapper and the Processes used. Edit, modify and keep it up to date with a few clicks.

Gap Report

Find gaps before the auditors do! Oversee what is in progress in which process and whether an item is pending, missing or needs further attention.

QMS Role Based Security

Have the right level of access controls by using role based permissions that make sure the right people have access to confidential data, tasks, projects and associated content.

Electronic Signatures - FDA QSR 21 part 11

When completing critical or high-importance actions, dual signature compliance functionality is used to securely and positively identify the authorized person.

QMS Workflow Processes

Reduce errors, forgotten paperwork and missed QMS reports through workflow processes that are not leaving any room for guessing what’s next, steps are defined, monitored and managed by management automatically.

Electronic Trail for Data

A signed document now has a date stamped electronic trail, that, if required, can be printed.

Tag Processes

Tag task as QMS process for easier follow-up and backtracking. See what tasks were undertaken to resolve QMS related issues within the context of the Project itself.

User Groups & Selective File Sharing

Reduce risks before they happen, or mitigate an undesired event by putting in place action plan controls. Easily track the recurrence of issues, analyze the impact of controls and measure the effectiveness of your action plans,
either short- or long term.

QMS Risk Reporting

Ensure the right people are getting the right information to be effective by
creating custom user groups.

Project Management

The visibility you need to make more informed decisions in real-time.

Fully Integrated Both Into and with QMS

Forget about using separate software applications for handling projects and another for QMS. Enable project-based collaboration to ensure FDA 510K or ISO 13485
team based compliance.

Balance Resources and Track Performance in Real Time

Assign the right work to the right team, with the right schedule to utilize resources more effectively. An open view of team workloads makes it easy to recalibrate when necessary.

Real-Time Project Visibility

Have instant visibility and traceability over your entire system operations at any stage of your project through the project summary report, including roadmaps, Gantt chart,
issue tracking details, etc.

Tags, QMS, Milestone, Versions

QMS Processes Driven Project Management

Create a full circle of follow-up and coordination for each quality objective, task and issue by driving your Projects through QMS Processes.

Custom Workflows

Simplify completing residual tasks by creating your own Custom Workflows to match exactly how your team works. They’re easy to implement and simple to use.

Project Workflow Editor

Customize the default Project Workflows or SOPs to fit your company’s particular workflow needs, or build new processes/workflows from scratch, just by following few simple steps.

Unlimited Projects

Get the flexibility you need to manage unlimited projects and subprojects, teams, tasks, issues, milestones, versioning, approval workflows, etc...All with one tool.

Subproject Support

Divide complex projects into easily manageable parts, like milestones, tasks, and subtasks.
The Subproject can inherit all properties of the parent Project

Issue Tracking

Have clear accountability and easily oversee activities through different product releases, including requirement origins, assignee history, tags, who executed the task, who approved,
which version etc.

One Ecosystem for All Issues

United interface and one system for every bug, issue, idea, or feature request.

Integrated with Storage

Organize and automatically store all project related files, discussions, and task in the actual project. QMS and projects follow each other in parallel.

Gantt–Chart

View your project schedule and set dependencies in a real-time visual timeline. Adjust, filter and manage easily to keep your team on track.

Risk Management

Complete Risk Assessment Aligned with ISO 14971

Fully Integrated into and With the QMS & PM Module

Have a complete and accurate picture of the risks across your products, processes, and teams with a complete risk assessment that is effective throughout your product’s entire lifecycle.

Flexible and Intuitive

Proportionate the flexible system to match the complexity and type of your organization. Accidental risk managers and risk manager professionals can both benefit.

Investigation

Risk Evaluation

Set severity of the harm and likelihood of occurrence of the harm and get automatically evaluated risk levels based on your organization’s predetermined risk acceptability threshold.

Analysis

Build a database by collecting production and post-production information throughout your product’s lifecycle. With the complete detail summary of the hazard analysis, it’s easy to find the underlining issue of your problems.

Action Plans

Reduce risks before they happen, or mitigate an undesired event by putting in place action plan controls. Easily track the recurrence of issues, analyze the impact of controls and measure the effectiveness of your action plans,
either short- or long term.

QMS Risk Reporting

Have automated QMS event generated after each risk step. Overview all QMS activities and enforce the right actions, for example,
a document approval workflow by category.

Document Management & Control

Track, Manage, Store and Bring Company Content Under Control

Centralized, Secure, Cloud Storage

Keep all your project files and critical compliance documents in the projects they were created, yet control, track and maintain complete visibility through single storage, cloud repository.

SOPs

Use default SOPs through Processes, or import your company specific ones, easy to modify or create entirely new, add them into any combination of folders or projects to
meet your needs.

DHFs

Produce the documents you need at each stage of production and simply generate your DHF.

Traceable File History

No more chasing lost or missing records! Prove regulatory compliance with a complete document traceability and file version history. Have evidence that the audit requires on-demand.

Version/ Change Control

Stop juggling multiple versions of the same document! Have complete document revision control through a centralized workspace, where everyone sees each other’s updates in real-time.

Drag and Drop Upload &Download

Upload as many documents as you'd like at once, either in a chat, or a project, or attach them to a meeting with a simple drag-and-drop, while keeping track of each version.

Document Approval Workflows

Simplify feedback and approval cycles without leaving your platform. Workflows are documented through reports, with full approval history. No confusion, re-work or delays.

QMS Processes & Documentation

Keep your team on the compliance track through QMS Processes. Checkpoints are integrated into the documentation flow to help streamline your FDA or ISO compliance activities.

QMS Vault

Lock and store QMS approved files in a secure Vault. No delete or change permitted, required for FDA compliance, version and permissions controlled, with full QMS histories, ensures the integrity of your QMS is never compromised.

PIN Signature (ERES)

Secure and Unique Electronic Document Signatures. Reduce risks, simplify compliance and speed up audits by using ERES and not wasting time on chasing people for signatures.

Relate/Assign Documents to QMS Folder

Use a process or manually relate/assign any storage file into the QMS Folder. Moved files are stored in the QMS Module, but for simplicity also remain viewable in the Storage.

Categorize, Classify, & Tag

Have a fast and effective search listing results by marking your files/records with keywords and advanced metadata tags.

Advanced Document Search

Easily find a needle in the haystack! Any document can be listed and filtered by any parameters, including the search for documents related to specific processes, projects, sub-projects, tags, type of documents, etc., search results can be printed if required.

Cloud Viewer

Files Stored by Projects

You work in projects, so Central Storage stores your files by project. This way users know where to find their files. A document added in a Project related Topic chat will be automatically saved in the corresponding project directory.

Check Out/ Check In files

Avoid confusion and unwanted multiple over-writes. Check out the file with a simple move and make sure no one else is making changes on the same document until you check it in again.

Internal Team Messaging

Integrated into all the Modules to Support your Project Development and Compliance Activities

Integrated Team Compliance

Give your Team-Compliance a level up, where everyone works together towards the desired quality outcomes. Track project changes, capture meetings, flag QMS and design changes across all the software modules.

Real Time Chat Conversations

Stay on top of your projects, documentation and QMS issues! No need for separate chat apps, no compatibility issues, no more losing focus from switching between apps.

Secure Internal Communication

Send and receive secure communication through the internal encrypted team messaging.

Attachments Synced with Storage

No more searching for lost attachments! Files shared or sent in a Chat are automatically stored in the Document Management, and can be linked to a particular project. Compliance made easy!

1-on-1 Conversation

Pick somebody’s brain or get fast answers from a particular colleague in a private
1-1 chat conversation.

Topics

Execute faster across distributed teams using topic-based, ongoing discussions with the full context of the work. Easy to follow and reference for the record later. A document added in a Project related Topic chat, will be automatically saved in the corresponding project directory.